Regulatory mechanism under attack
Organizations denounce in UN threat to access to medicines in Brazil
A network of civil society organizations sent an urgent appeal today, November 4, to the United Nations special rapporteur on the Right to Health, Dainius Pûras, denouncing the threat to access to medicines in Brazil.
According to GTPI/Rebrip (Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples), a group of organizations that promotes access to health, rulings by the Attorney General’s Office have undermined the role of Anvisa (National Health Regulatory Agency) in the process of analyzing drug patent requests.
Click here to read the urgent appeal in full.
For a patent to be granted in Brazil, it is required by law to have what is known as the ‘prior consent of Anvisa’, a mechanism created in 2001 that coordinates the work of the regulatory agency and the INPI (National Industrial Property Institute) to ensure that examinations are more rigorous and to make it less likely for patents to be granted unduly.
According to civil society, this is an important health protection measure that has been praised by international organisms, experts and even the WHO (World Health Organisation).
The legal interpretation made by the Attorney General’s Office, however, allows drug makers to file legal cases challenging the role of Anvisa.
“The dismantling of a mechanism created to protect the right to health is a human rights violation. The right to health comes before the profit of companies. Brazil needs to fulfill its duty to guarantee access to medicines and prevent the actions of companies that violate human rights. The ruling of the Attorney General’s Office urgently needs to be modified,” said Marcela Vieira, a lawyer and the coordinator of GTPI. “This is the second complaint made in the UN on the matter. The first was made in 2011 and was never responded to by the Brazilian State, according to the Office of the Rapporteur,” she said.
The intention of the group of organizations is for the UN to formally remind Brazil of its obligations in relation to the right to health and to request information on what it has done to protect the prior consent of Anvisa.
Through the granting of patents, drug companies are given monopolies on the sale of their products, allowing them to raise prices. Given the high cost of patented medicines, the granting of undue patents can make drugs unaffordable for consumers and threaten the sustainability of public policies of free access to medicines. In 2014, the amount spent by the Ministry of Health on the acquisition of medicines was R$7.65 billion, representing 7.5% of its total budget, according to data provided by the Ministry of Health via the Freedom of Information Law.
